Emergency PCI in the GTA: From Myth to Reality

1. Emergency PCI in the GTA:From Myth to Reality Introduction: Dr. Vlad Dzavik The York-Simcoe Regional Primary PCI Program Dr. Warren Cantor The UofT Hospitals initiative Dr. Vlad Dzavik Current Emergency PCI Status and initiatives at St. Michael’s Dr. Neil Fam at Sunnybrook Dr. Dennis Ko at UHN Dr. Chris Overgaard EMS Initiatives Alan Craig Prehospital fibrinolysis or direct transport for primary PCI in acute STEMI (PREDESTINY): A proposal for a randomized controlled trial Background Dr. Shaun Goodman Protocol Dr. Laurie Morrison Discussion University of Toronto City-wide Cardiology Rounds November 29, 2007

2. University of Toronto City-wide Cardiology Rounds November 29, 2007

3. University of Toronto City-wide Cardiology Rounds November 29, 2007

4. Keeley et al. Lancet 2003; 361:13–20 University of Toronto City-wide Cardiology Rounds November 29, 2007

5. Metanalysis of 23 Trials Keeley et al. Lancet 2003; 361:13–20 University of Toronto City-wide Cardiology Rounds November 29, 2007

6. D2B TIME AND MORTALITYNRMI REGISTRY McNamarra et al. JACC Vol. 47, No. 11, 2006 University of Toronto City-wide Cardiology Rounds November 29, 2007

7. NRMI 2-4: PCI-related delay where PCI and Thrombolysis mortality rates are equal University of Toronto City-wide Cardiology Rounds November 29, 2007

8. bradley et al. www.nejm.org november 30, 200 University of Toronto City-wide Cardiology Rounds November 29, 2007

9. bradley et al. www.nejm.org november 30, 2006 University of Toronto City-wide Cardiology Rounds November 29, 2007

10. Number of Strategies and Door-to-Balloon Time bradley et al. www.nejm.org november 30, 2006 University of Toronto City-wide Cardiology Rounds November 29, 2007

11. Regional Primary PCI Southlake Regional Health CentreWarren J. Cantor, MD, FRCPCPhysician Director, Regional Primary PCI ProgramAssistant Professor of Medicine, Univ. of Toronto 9803mo01,

12. Regional Cardiac Care Program at SRHC • 1998 – MOH designated former York County Hospital to be an Advanced Regional Cardiac Centre for York Region, Simcoe County & Muskoka to provide PCI, cardiac surgery & PPM • Redevelopment in 2002, $170 million capital expansion • 1st PCI Nov 2003 • Serve 11 hospitals, over 1 Million residents served • York Region & Simcoe County are the fastest growing areas in Canada 9803mo01,

13. PCI Volumes at SRHC 9803mo01,

14. Regional Cardiac Care Program at Southlake Regional Health Centre One of the major goals is to provide best management for all STEMI patients within our region 9803mo01,

15. Primary PCI vs. Thrombolysis Short-term outcomes PTCA Thrombolytic Therapy 23 trials n=7,739 Frequency (%) Long-term outcomes Death, excluding SHOCK Death / MI / Stroke Death MI Recurrent Ischemia Stroke Hemorr. Stroke Major Bleed 9803mo01, —Keeley EC, Lancet 2003

16. Door-to-Balloon Time 10 In-Hospital Mortality P<0.001 P<0.001 8.5 8 7.9 P<0.001 6.7 6 Percentage of patients with events p=0.08 p=0.51 5.1 4.6 4 4.2 2 n=2230 n=5734 n=6616 n=4461 n=2627 n=5412 0 >180 0-60 121-150 91-120 61-90 151-180 Door-to-Balloon Time (minutes) NRMI-2 27,080 pts Goal: Door-to-Balloon Time ≤ 90 minutes 9803mo01, Cannon CP, et al. JAMA 2000

17. 2004 ACC/AHA Guideline Considerations • Primary PCI generally preferred • Skilled PCI lab available (med contact to balloon < 90 min) • High risk STEMI (cardiogenic shock, Killip class ≥3) • Contraindication to lysis • Late presentation (>3 hrs) • Diagnosis in doubt Fibrinolysis generally preferred • Early presentation (≤ 3h from sx onset and delay to invasive strategy) • Invasive strategy not an option (cath lab not available, no vasc access, lack of skilled PCI lab) • Delay to Invasive Strategy med contact to balloon >90 ACC/AHA STEMI Guidelines 2004, Figure 3

18. 6 Proven Strategies to Reduce Door-to-Balloon Times • Having emerg physicians activate the cath lab • Having a single call to a central page operator activate cath lab • Having the emergency dept activate the cath lab while the patient is en route to the hospital • Expecting staff to arrive in the cath lab within 20 minutes after being paged (vs. >30 minutes) • Having an attending cardiologist always on site • Having staff in the emerg dept and the cath lab use real-time data feedback 9803mo01, Bradley EH, N Engl J Med 2006

19. 6 Proven Strategies to Reduce Door-to-Balloon Times • Having emerg physicians activate the cath lab • Having a single call to a central page operator activate cath lab • Having the emergency dept activate the cath lab while the patient is en route to the hospital • Expecting staff to arrive in the cath lab within 20 minutes after being paged (vs. >30 minutes) • Having an attending cardiologist always on site • Having staff in the emerg dept and the cath lab use real-time data feedback 9803mo01, Bradley EH, N Engl J Med 2006

20. How our PPCI program was implemented • Identified by Division & senior hospital administration as priority for hospital & region • EMS & base hospital directors invited to join committee which met regularly to plan implementation • “Mock” run-in done to assess paramedic ECG interpretation, patient volume, impact on beds • Start with late-presenters to minimize impact of any potential treatment delays related to transfers 9803mo01,

21. Primary PCI - SRHC Emerg Dept • Started 24/7 Primary PCI March 1/06 • Approx 60 pts / yr (5 pts / month) • Median Door-to-Balloon Time: 85 min • Emerg MD calls ‘Code STEMI’, directly activates cath lab • STEMI nurse gets patient up to cath lab quickly • Immediate feedback to ED after each case • Feb /08- EMS will bypass SRHC emerg dept 9803mo01,

22. Primary PCI – Simcoe EMS • Jan/07- STEMI pts in Simcoe County ambulances brought directly to SRHC for primary PCI (Late presenters or contraindications to lysis) if within 45 min to SRHC • Paramedics directly activate cath lab, STEMI nurse meets EMS at front door & accompanies to cath lab • 16 patients, Median Time from EMS arrival at scene to 1st Inflation: 95 minutes • Median 53 min from ECG to arrival in cath lab • Only 1 incorrect ECG interpretation (paced rhythm) 9803mo01,

23. 9803mo01,

24. Distances to SRHC RVH: 58 km Stevenson: 51 km 9803mo01,

25. Primary PCI – RVH Emerg dept • Feb/07- STEMI pts in RVH Emerg Dept (“walk-ins”) transferred to SRCH for primary PCI (Late presenters or contraindications to lysis) • Transfer time from RVH to cath lab: 46 min • Time from ECG to ED departure remains too long • Developing strategies to minimize delays (eg. abciximab pretreatment eliminated- FINESSE) 9803mo01,

26. RVH STEMI Algorithm History & ECG consistent with ST-elevation MI * Does patient have cardiogenic shock OR Absolute contraindications to thrombolysis? * YES NO NO Did symptoms start > 3 hours (and < 12 hours) ago? YES Call EMS- “Code STEMI, Code 4” Anticipate arrival at SRHC within 60 minutes of diagnostic ECG? NO YES Call Southlake Dispatch 905-895-4521 ext 7777 “Code STEMI - RVH” ASA 160 mg po Clopidogrel 600 mg po Heparin 70 U/kg (≤ 7000 U) bolus Send for 1o PCI Consider Thrombolysis + TRANSFER-AMI if eligible * If diagnostic uncertainty or relative contraindications to thrombolysis, page interventional cardiologist on-call 905-895-4521 ext 2216 Transfer for Rescue PCI if required 9803mo01,

27. Prehospital vs. Emerg Dept • Treatment times much quicker when STEMI diagnosed pre-hospital • “Walk-In” patients often have more atypical, milder symptoms • ED pts face additional delay of waiting for ambulance • Physicians tend to slow down the process • Less protocol-driven • Initially reluctant to activate cath lab without discussing case with another MD first • Many different Emerg MD’s, each seeing only few STEMI’s per year 9803mo01,

28. Regional Primary PCI Program- Principles • Direct EMS / Emerg MD activation of cath lab • Bed must always be available • STEMI nurse in CCU available • Repatriation within 24 hrs 9803mo01,

29. Regional Primary PCI Program- Principles • Direct EMS / Emerg MD activation of cath lab • Bed must always be available • STEMI nurse in CCU available • Repatriation within 24 hrs 9803mo01,

30. Code STEMI “Hotline” • Ext 7777 answered immediately by hospital operator 24/7 • Only 3 questions asked: EMS vs. ED, location, ETA • Cath lab staff, interventionalist, STEMI nurse paged simultanously 9803mo01,

31. Regional Primary PCI Program- Principles • Direct EMS / Emerg MD activation of cath lab • Bed must always be available • STEMI nurse in CCU available • Repatriation within 24 hrs 9803mo01,

32. Working Model • STEMI Beds • Pre-PCI preparation • Post-PCI high-risk • Virtual bed • PCI Unit • Repatriation Unit • STEMI Nurse Southlake – 5th Floor PCI Lab CCU STEMI beds Duration of stay < 24 hrs PCI Unit Elevators Cardiology Ward Bed status is never checked prior to activating cath lab for primary PCI

33. Repatriation • Stable patients routinely repatriated within 24 hrs of PCI • Formal repatriation agreement developed with RVH, MSH, OSMH, YCH • Includes patients who were brought by EMS, never seen in community hospital 9803mo01,

34. Lessons learned • The fewer physicians involved in decision-making the better • Gradual implementation in steps works best • Need complete ‘buy-in’ from hospital administration, EMS, community hospitals • Start with late presenters until ‘well-greased’ system in place for consistent rapid transfers • Keep protocol as simple as possible 9803mo01,

35. Future Directions • ECG Transmission • Prehospital Thrombolysis (Predestiny) • Pharmacoinvasive Strategy (Transfer-AMI) 9803mo01,

36. PCI Centre Cath Lab Community Hospital Emergency Department ‘High Risk’ ST Elevation MI within 12 hours of symptom onset N=1200 TNK + Heparin / Enoxaparin + Clopidogrel Urgent Transfer to PCI Centre Standard Treatment Assess chest pain, ST↑ resolution at 60-90 minutes Failed Reperfusion Successful Reperfusion Cath / PCI within 6 hrs “Pharmacoinvasive Strategy” Cath and Rescue PCI ± GP IIb/IIIa Inhibitor Elective Cath ± PCI > 24 hrs later Primary Endpoint: 30-day death / re-MI / CHF / severe recurrent ischemia/ shock Secondary Endpoints:Major bleeding, 90-minute ST↑ resolution, ECG- and Echo-derived infarct size / extent 9803mo01, Cantor WJ. Am Heart J, In Press

37. 1044 pts 9803mo01,

38. Primary PCI Other strategies 9803mo01,

39. ACUTE MI PCI University of Toronto Hospital Initiatives University of Toronto City-wide Cardiology Rounds November 29, 2007

40. IMPROVING ACUTE MI CAREPHASE ONE • The three University of Toronto Interventional Cardiology Programs, St. Michael’s Hospital, Sunnybrook Health Sciences Centre and the University Health Network, have agreed in principle to improve and optimize existing emergent interventional services by joining forces and thus providing a ‘guaranteed accept’ 24/7 service for patients in the region requiring interventional care for failed thrombolysis, very high risk patients in cardiogenic shock or advanced Killip class, and those with contraindications to thrombolytic therapy. This service, agreed to and signed off on by the Administration of each of the three hospitals, St. Michael’s Hospital, Sunnybrook Hospital and the University Health Network, will apply the following principles: 43 University of Toronto City-wide Cardiology Rounds November 29, 2007

41. PHASE ONE • A single contact number to reach emergent interventional care administered by CritiCall • A call schedule involving the three programs will be made available to Criticall • The interventional cardiologist on call will be the contact at the receiving interventional cardiology centre • There will be a NO REJECT policy, as is currently the case with trauma and in some centres organ transplants. • In the case that the primary interventional on-call team is already in the midst of an emergent procedure, the second on-call centre will be contacted by CritiCall to accept a new patient. • Patients transferred from community hospitals who are deemed stable following the interventional procedure will be transferred back to that hospital within 24 hours of the procedure and could be transferred as soon as the procedure is done and acute vascular access site care has been completed. 44 University of Toronto City-wide Cardiology Rounds November 29, 2007

42. RECOMMENDED TARGETS • Door-to-ECG <10 minutes • ECG-to-ER Decision <10 minutes • Decision-to- Cath Lab <20 minutes • Cath Lab-to-Balloon <30 minutes University of Toronto City-wide Cardiology Rounds November 29, 2007

43. PHASE 2 • In the second phase, the University interventional cardiology programs will implement the elements necessary to establish a timely and efficient 24/7 program for primary PCI for patients arriving by ambulance or walking into their own institutions. The ideal call-to-arrival time of CCL staff of <30 minutes must be implemented in this phase by the means most achievable in each individual centre. The possible options that can be implemented include the following: • An evening shift that would extend to 11 pm or midnight • Ensuring that at least one of the on-call nurses for a particular night lives within a 30 minute radius of the hospital • Ensuring that all interventional cardiologists and fellows can be in the hospital within 30 minutes. • Cross-training of CICU nurses to help begin an emergent procedure until the arrival of the CCL on call nurses and possibly to assist during the entire procedure 46 University of Toronto City-wide Cardiology Rounds November 29, 2007

44. PHASE 3 • In the third phase the University of Toronto interventional cardiology collaboration will implement a strategy of performing primary PCI for eligible patients presenting to GTA hospitals or identified by EMS in the pre-hospital phase. • Implementation timelines • Phase 1 is to be implemented by July 1, 2007 • Phase 2 is to be implemented by April 1, 2008 • Phase 3 is to be implemented by July 1, 2008 University of Toronto City-wide Cardiology Rounds November 29, 2007

45. STEMI Initiatives • Dennis T. Ko MD MSc FRCPC • Interventional Cardiologist, Sunnybrook Health Sciences Centre • Scientist, Institute for Clinical Evaluative Sciences • University of Toronto • TCT October 23, 2007 Enhancing the effectiveness of health care for Ontarians through research 48

46. Objectives • Discuss local STEMI initiative at Sunnybrook Health Sciences Centre • Discuss ongoing national initiatives and opportunities

47. PCI versus Fibrinolysis with Fibrin-Specific Agents: Is Timing (Almost) Everything? 10 − 13 RCTs N = 5494 P = 0.04 5 − Favors PCI Absolute Risk Difference in Death (%) 0 − Favors fibrinolysis -5 − ┬ ┬ ┬ ┬ ┬ ┬ • 40 50 60 70 80 PCI-Related Time Delay (minutes) Nallamothu and Bates. Am J Cardiol 2003;92:824.

48. Recommendation for reperfusion therapy • Minimize delay to reperfusion • Door to needle: <30 minutes • Door to balloon: <90 minutes • Not “Median”, but all patients should be treated within the recommended timeframe

49. EFFECT STUDY (99-01) Reperfusion Therapy 100 80 60 Percent 75% 40 59% 20 0 All STEMI patients Ideal* STEMI patients *Ideal as per GRACE Registry criteria

50. EFFECT STUDY (99-01) Door-to-Needle time for thrombolytic therapy 60 50 46 40 40 40 Median Time in Minutes Benchmark < 30 Minutes 30 20 10 Teaching Comm Small Average = 40 min 6/41 hospital corps met benchmark